USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device
Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
UK MHRA Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Switzerland's SwissMedic: Guidance on Export Certificates
Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies